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The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01197092
Enrollment
40
Registered
2010-09-09
Start date
2010-11-30
Completion date
2011-01-31
Last updated
2010-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Keywords

Diabetes

Brief summary

A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well as its risk factors.

Interventions

DIETARY_SUPPLEMENTMitochondrial preparations

Oral therapy with mitochondrial preparations based on recipes of Dr Kremer and the Tisso company: ProEMSan (large intestinal symbionts with 31 strains of bacteria) Pro Basan (small intestinal symbionts) ProSirtusan (Polyphenol-mix and vitamins) ProVita D3 (Vitamin D3 supplement) ProOmega (Omega 3-fatty acid preparation) ProCarnitin (Carnitine-preparation) ProSango Vital (trace element preparation)

DIETARY_SUPPLEMENTInfusion therapy

Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.

DEVICEWebermedical device

Intravenous-Blood-Laser-Therapy: the Webermedical device will be used

Nutritional therapy based on IgG-blood results. Significant antibody-formation against foodstuffs will be ascertained (in foodstuffs evaluated through the BioMedicalScreen), will be taken out of the diet - the background being the additional lowering of risk potential of those antibodies causing the so called silent inflammation (sub-clinical inflammation) -ultimately an anti-inflammatory diet will be given in the protocol. The following have special focus: gluten, cow's milk, fish, meat, nuts.

Sponsors

Center for Integrative Medicine, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* men and women between the ages of 18 and 60 * recently diagnosed Diabetes Type II (within the last 12 months)

Exclusion criteria

* no orally-taken medication up to present * no insulin therapy * no diseases resulting from diabetes like Nephropathy, Neuropathy, Angiopathy or Retinopathy * fasting blood sugar values in the morning under 200mmol * sufficient production of insulin

Design outcomes

Primary

MeasureTime frameDescription
HbA1c Test (Glycated hemoglobin)4 month averageLaboratory test

Secondary

MeasureTime frameDescription
Electrolytes4 month averageLaboratory test
Liver, pancreatic and kidney retention values4 month averageLaboratory test
Lipids: Cholesterol,Triglycerides4 month averageLaboratory test
Oxyd LDL (low-density lipoprotein cholesterol)4 month averageLaboratory test
Free lipids fasting4 month averageLaboratory test
Lipoprotein A4 month averageLaboratory test
Fibrinogen4 month averageLaboratory test
CRP (C Reactive protein)4 month averageLaboratory test
Blood count4 month averageLaboratory test
Homocysteins4 month averageLaboratory test
Nutrient IgGs Panels (BiomedicalScreen)4 month averageLaboratory test
Insulin, Adiponectin, Leptin4 month averageLaboratory test
Potassium, selene, magnesium, zinc in whole blood4 month averageLaboratory test
SHbG, full-testosterone (Androgen-Index)4 month averageLaboratory test
PlasminInhibitor I4 month averageLaboratory test
Vitamins B1,B2,B6,B 12, Vitamin D4 month averageLaboratory test
LDH-Isoenzymes (Lactate dehydrogenase)4 month averageLaboratory test

Countries

Germany

Contacts

Primary ContactRainer Mutschler, MD
mutschler@cfi-speyer.de06232 - 28 90 88 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026